A Registry Study on Xiyanping(a Chinese Medicine Injection) Used in Fifty Hospitals

• Conditions: Bronchitis; Bacillary Dysentery; Viral Pneumonia; Infantile Diarrhea; Virus Hepatitis

• Registration Number: NCT01612572
• Lead Sponsor: China Academy of Chinese Medical Sciences

Brief Summary

This study was advocated by Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences in October 2011.

It was funded by China major scientific and technological specialized project for 'significant new formulation of new drugs'.

Xiyanping is kind of Chinese Medicine injection used for treating viral pneumonia 、bronchitis、amygdalitis、infantile diarrhea、bacillary dysentery 、virus hepatitis、and Children acute hot diseases in many Chinese hospitals.

The purpose of this study is to determine adverse drug events or adverse drug reaction in large sample size 20,000 patients.

Detailed Description

It is very common that Chinese Medicine Injection used in hospitals in mainland China. However safety problems rose in recent years. There could be many uncertain factors influence Chinese Medicine Injection in clinical practice.

In order to ensure the safety of public drug use and lower drug-induced risks, a registry study for Xiyanping injection safety surveillance with 20000 patients will be conducted from Jan.2012 to Dec.2015.

Eligibility criteria Patients who will use Xiyanping injection in selected hospitals.

Study Timeline

• Study Start: 2012-01
• Status Verified: 2012-06
• Study First Submitted: 2012-06-03
• Study First Submitted QC: 2012-06-05
• Last Update Submitted: 2012-06-05
• Study First Posted: 2012-06-06
• Last Update Posted: 2012-06-06
• Primary Completion: 2014-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20000

Inclusion Criteria

• Xiyanping injection from 2012 to 2014

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of participants with adverse events; incidence of Xiyanping'ADRs and identify factors that contributed to the occurrence of the adverse reaction	The registry procedure will last 3 years only for patients using Xiyanping.